ConvaVAC™ Ag+ Negative Pressure Wound Therapy System in Chronic Wounds (NCT07342049) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
ConvaVAC™ Ag+ Negative Pressure Wound Therapy System in Chronic Wounds
87 participantsStarted 2026-01-12
Plain-language summary
Purpose of this study is to learn more about how safe and effective the ConvaVAC™ Ag+ wound therapy system is in treating certain types of long-lasting wounds, called chronic wounds. In this study, the focus is on Venous Leg Ulcers (VLUs). Chronic wounds are wounds that do not heal properly or take a long time to heal. They can cause pain, discomfort, and affect your day-to-day life. These types of wounds are also challenging for healthcare teams to treat and can take up a lot of healthcare resources. Venous Leg Ulcers (VLUs) are the most common type of chronic leg wound and affect about 1 in every 100 people. Usual treatments for VLUs include cleaning the wound, using special dressings, applying pressure (compression therapy), and sometimes using creams or dressings that contain silver to fight infection. This study is being done to see if the wound therapy system can help heal venous leg ulcers more effectively and safely.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* A wound which is amenable to NPWT and is a VLU as defined by CEAP Classification of C6 or C6R
* Wounds that are clean or contaminated
* Wounds with at least one sign or symptom of infection
* Wounds that in the opinion of the investigator would benefit from an antimicrobial dressing
* ≥18 years old at the time of consent
Exclusion Criteria:
* Known sensitivities or allergies to components of the ConvaVAC™ Ag+ NPWT System
* Ischemic wounds with necrotic tissue or eschar present that require sharp debridement
* Wound is too small or too large based on wound dressing size (\> 0.5cm2 and \< 100cm2)
* Wound depth \>7cm
* Wounds requiring concomitant use of DuoDERM® gel, hydrogels, petroleum-based creams/ ointment-/gels per the opinion of the investigator
* Active chemotherapy, radiation therapy, or immunotherapy for cancer or completed treatment within the last 3 months
* Any active malignancy at site of dressing application
* Exposed bone in target wound
* Exposed blood vessels or nerves in target wound
* Systemic infection and/or systemic inflammatory response syndrome (SIRS), sepsis
* Cellulitis in target wound
* Untreated deep tissue infection including but not limited to osteomyelitis, septic arthritis
* Active Pregnancy
* Subjects that in the opinion of the investigator are not suitable for enrollment
* Vulnerable subjects as determined by ICH Harmonized Guideline, Good Clinical Practice E6(R2)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage area reduction (PAR) in wound size at day 14